Intraoperative estimation of intraocular lens power

ABSTRACT

Apparatus for performing intraocular implant surgery, including surgical apparatus for performing intraocular implant surgery, an autorefraction device associated with the surgical apparatus, wherein the autorefraction device is configured to perform autorefraction on the aphakic eye to provide one or more aphakic refraction measurements, and a processor connected to the autorefraction device, wherein the processor is configured to process the aphakic refraction measurements and provide the user of the apparatus with information regarding the power of the intraocular lens.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of and claims priority toU.S. application Ser. No. 12/499,079, filed on Jul. 7, 2009, whichapplication is a divisional application of and claims priority to U.S.application Ser. No. 10/820,635, filed on Apr. 8, 2004. This applicationalso claims priority to U.S. Provisional Application Ser. No.60/461,429, filed on Apr. 10, 2003. The disclosures of the priorapplications are considered part of (and are incorporated by referencein) the disclosure of this application.

TECHNICAL FIELD

This invention relates to methods and apparatus for selecting the powerof an intraocular lens to be implanted into an eye.

BACKGROUND

The history of intraocular lens implantation dates back to 1949 when aninitial attempt to replace a diseased lens with an artificial oneresulted in a poor outcome with an error of −24.0 diopter (D).Nevertheless, this set the stage for continuous advances in the field ofophthalmology, leading to the common practice of “standard-of-care” lensimplantation we see today. The technology of cataract surgery haswitnessed an impressive development through constant innovation ofsurgical technique and instrumentation, lens material and design, andjust as importantly, ever improving methodology for calculating andpredicting the power of the lens implant necessary to achieve desiredpostoperative refractive outcome. In the 1960s Fyodorov was the firstscientist to publish a formula for predicting the power of theintraocular lenses (IOLs) based on geometrical optics incorporating twovery important preoperative anatomical parameters of the ocular system.A-scan derived axial length of the eye and keratometry measurements ofthe cornea, Feodorov S N, Kolinko A L. Estimation of optical power ofthe intraocular lens. Vestn. Oftamol; 80(4):27-31 (1967). Colenbranderpublished the first formula written in English in 1973. Colenbrander,Calculation of the Power of an Iris-Clip Lens for Distance Vision, Br.J. Ophthal. 57:735-40 (1973). Many further improvements followed thesepioneering efforts. Binkhorst described a derivative formula in the1970s. Binkhorst R D., The optical design of intraocular lens implants.Ophthalmic Surg 1975; 6(3):17-31. Binkhorst, Power of the Pre-PupillaryPseudoshakos, B.J.O. 56:332-37, (1972)). Modifications of theColenbrander formula were implemented by Dr. Hoffer with furtherimprovement of accuracy across the different axial length ranges. HofferK J. Mathematics and computers in intraocular lens calculation. AmIntra-Ocular Implant Soc J 1975; 1(1):4-5). In 1980, Sanders, Retzlaffand Kraff derived a regression formula which has sustained manysubsequent updates and modifications. Further refinements were achievedwith the second generation formulas which had better precision over awider range of anatomic parameters, but all used axial length andcorneal curvature (keratometry) as the main predictive variable in theirmodels. Sanders, J. Retzlaff & M. C. Kraff, Comparison of the SRK IIFormula and the Other Second Generation Formulas, J. Cataract &Refractive Surg. 14(3):136-41 (1988). Olsen, T., Theoretical Approach toIOL Calculation Using Gaussian Optics, J. Cataract & Refractive Surg.13:141-45 (1987). Holladay, T. C. Praeger, T. Y. Chandler & K. H.Musgrove, A Three-Party System for Refining Intraocular Lens PowerCalculations, J. Cataract & Refractive Surg. 14:17-24 (1988). J. T.Thompson, A. E. Maumenee & C. C. Baker, A New Posterior ChamberIntraocular Lens Formula for Axial Myopes, Ophthal. 91:484-88 (1984).Various improvements in making preoperative anatomic-based estimates ofIOL power have been described in the patent literature (e.g., U.S. Pat.Nos. 6,634,751, 5,968,095, and 5,282,852).

The shortcomings of current technology are multifold. Even in the idealand most simplified clinical setting, about 10-20% of patients remainwith at least 1.0 diopter refractive error after surgery. In about 3-5%of cases this residual can be as high as 2 diopters. Also, traditionalIOL estimation techniques based on axial length and corneal curvatureproduce even greater inaccuracy when the cataract surgery is done aftervision correcting refractive surgery (e.g., Lasik, Lasek, wavefront andother similar corrective procedures). In this setting, a larger residualerror can result (e.g., more than about 80% of such cases have about1-1.5 diopter error). Reliance on anatomic measurements is even moreproblematic for a patient whose eye shape is at the extreme end of therange of an anatomic parameter.

Autoretinoscopy has been traditionally used for determination of theoptical state of the ocular system in an office visit. In this officesetting, autoretinoscopy is used as an objective measurement to guidethe subjective testing and estimation of the power for corrective eyeglass prescription. In this setting, an autorefractor based on theprinciple of automated retinoscopy, is used with the eye in the phakicstate (i.e., with the native lens in its native position). A number ofwidely available autoretinoscopes are employed with the patient in asitting position in front of the apparatus.

In recent years, very significant advances have been made in IOLsurgical techniques and instrumentation (e.g., microincision techniquesfor quick and controlled cataract surgery), but IOL power has continuedto be estimated preoperatively using anatomic measurements.

SUMMARY

The problems associated with current methods for IOL power estimationlie in the reliance on preoperative measurements, e.g., cornealcurvature and axial length. These parameters can change significantlyafter the eye has been manipulated. For example, the curvature of thecornea and its optical properties change after incisions and intraocularprocedures. Current models extrapolate the effective lens position ofthe implant through lens-associated constants, such as the A-constant,which are inherent to the specific lens design, but not to theparticular anatomy of each eye, and therefore not individuallycustomized to each surgical case. The current methods, because they onlyapproximate the optical deficiency of the eye after lens extraction,lead to residual errors in lens power.

In a first aspect, the invention features a method for selecting thepower of an intraocular lens, comprising extracting the native lens,performing autorefraction on the aphakic eye to provide one or moreaphakic refraction measurements, and determining the power of theintraocular lens from the one or more aphakic refraction measurements.

Preferred implementations of this aspect of the invention mayincorporate one or more of the following. The autorefraction may beperformed with the patient in the same position in which the native lenswas extracted. The position of the patient may be the supine position.The method may be used for patients that have previously undergonevision correcting refractive surgery. Determining the power of theintraocular lens may comprise using a predictive model that is anempirically derived relationship between the autorefraction measurementsand the power of the intraocular lens. Determining the power of theintraocular lens may comprise using a predictive model that is atheoretically derived relationship between the autorefractionmeasurements and the power of the intraocular lens. The native lens maybe extracted using a surgical microscope and the autorefraction may beperformed using an autorefraction device configured to be moved intoplace for making autorefraction measurements following extraction of thenative lens using the surgical microscope. The autorefraction maycomprise making a plurality of autorefraction measurements and averagingthe measurements. Determining the power of the intraocular lens maycomprise determining the power from the one or more autorefractivemeasurements and from other parameters. The other parameters may includepreoperative anatomic measurements of the eye. They may also include oneor more of the following: intraocular pressure, intraoperative axiallength, intraoperative keratometry, preoperative keratometry,preoperative axial length, intraoperative anterior chamber depth, orpreoperative anterior chamber depth.

In a second aspect, the invention features apparatus for performingintraocular implant surgery, comprising surgical apparatus forperforming intraocular implant surgery, an autorefraction deviceassociated with the surgical apparatus, wherein the autorefractiondevice is configured to perform autorefraction on the aphakic eye toprovide one or more aphakic refraction measurements, and a processorconnected to the autorefraction device, wherein the processor isconfigured to process the aphakic refraction measurements and providethe user of the apparatus with information regarding the power of theintraocular lens.

Preferred implementations of this aspect of the invention mayincorporate one or more of the following. The apparatus may furthercomprise a display for providing the user of the apparatus with theinformation regarding the power of the intraocular lens. Theautorefraction device may be attached to or integrated with the surgicalapparatus. The surgical apparatus may be a surgical microscope and theautorefraction device may comprise an autorefraction device configuredto be moved into place for making refraction measurements followingextraction of the native lens using the surgical microscope. Theautorefraction device may be a portable autorefraction device that isused while a patient is in the supine position following surgicalextraction of the lens. The autorefraction device may comprise aretinoscope. The autorefraction device may comprise a wavefront-basedautorefraction device. The autorefraction device may comprise apparatusfor measuring the aphakic dioptric state, the deficiency of the ocularsystem, or both the aphakic dioptric state and the deficiency of theocular system. The autorefraction device may comprise or work incombination with an external lens, contact lens, intraocular lens, orother component with refractive or medium properties positioned alongthe optical axis along an autorefraction measurement trajectory. Thesurgical apparatus may comprise a surgical microscope that includes anocular piece or display for centration and positioning and a toggle forXYZ movement, and wherein the autorefraction device may be positionedand configured so that movement of the toggle can adjust the position ofthe autorefraction device relative to the eye.

Among the many advantages of the invention (some of which may beachieved only in some of its various aspects and implementations) arethe following: Greater precision is possible in estimating required IOLpower, and thus there is less residual refractive error. It is possibleto achieve reductions in the complexity and cost associated with IOLimplantation surgery (e.g., it may be possible to eliminate the need forexpensive equipment such as an A-scan biometry device and a keratometer,as well as the need for a separate pre-operative patient visit at whichpre-operative eye measurements are made). The invention makes itpossible to break away from the conventional preoperative anatomicalapproaches derived from Feodorov's original work in 1967. New refractivemeasurement technology can be used to predict the power of theintraocular lens. Anatomic parameters such as preoperative axial lengthand keratometry are no longer essential to the process of estimating thepower of the intraocular lens (but these parameters, as well as others,may, in some implementations, be used in combination with theintraoperative autorefraction measurements). Relying on intraoperativemeasurement of the aphakic refractive state of the eye after lensextraction has the advantage that it measures the optical deficiency ofthe ocular system without the confounding interference of the nativelens. Modem retinoscopy technology can be adapted to cataract surgeryimmediately after extraction of the cataract, when the eye istransiently aphakic; in this state, the cornea is the primary refractivemedium and the optical system of the eye is in a unique state ofnon-interference by the lenticular optical component. When anautorefraction or other form of retinoscopy is done before a lens isimplanted, the measurements are primed to correlate closely with themissing intraocular lens power. From these measurements the surgeon onecan derive, correlate and calculate the parameters of the lens to beinserted. The method can be used solely for the purposes described or incombination with other ocular measurements and parameters obtained prioror during surgery to optimize accuracy and precision.

Other features and advantages of the invention will be found in thedetailed description, drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is flow chart of steps in one implementation of the invention.

FIG. 2 is a diagrammatic view of apparatus implementing the invention inpone possible manner.

DETAILED DESCRIPTION

There are a great many possible implementations of the invention, toomany to describe herein. Some possible implementations that arepresently preferred are described below. It cannot be emphasized toostrongly, however, that these are descriptions of implementations of theinvention, and not descriptions of the invention, which is not limitedto the detailed implementations described in this section but isdescribed in broader terms in the claims.

FIG. 1 shows the process followed in one implementation of theinvention. Any surgical technique for lens extraction may be used,including such conventional techniques as phacoemulsification orextracapsular cataract extraction. After the lens is extracted from theeye and all particulate lens material is removed, the anterior chamberis maintained formed with intraocular fluid or viscoelastic. The eye isthen centered and an autorefracting device is used to obtain arefractive reading of the aphakic eye (i.e., the eye with the lensremoved). While any autorefractor can be used across a wide range ofpossible vertex distances, one possible implementation is to use anautorefractor with a vertex distance of 13.75 mm, and to take an averageof multiple autorefraction measurements. Autorefraction provides aspherical and a cylindrical power measurement.

The power of the intraocular lens can be derived from the refractionmeasurements. One possible method for deriving the intraocular lenspower is to use an empirically derived relationship, which could becalled a predictive IOL model, that relates the refraction measurementsto the IOL power. This can be done, for example, by first calculatingthe aphakic spherical equivalent of the refraction measurements from thestandard formula:

Spherical Equiv=Measured Spherical Power+½Measured Cylindrical Power,

wherein Spherical Equiv is the aphakic spherical equivalent, MeasuredSpherical Power is the average of the spherical power measurements madeusing autorefraction, and Measured Cylindrical Power is the average ofthe cylindrical power measurements made using autorefraction. Next, thefollowing empirically derived relationship may be used to relate theaphakic spherical equivalent to the IOL power:

IOL Power=A+c+b*(Spherical Equiv),

wherein A is the lens specific constant (and depends on the type ofintraocular lens being implanted), c is an empirically derived constant,and b is the empirically derived linear correlation coefficient.

The two empirically derived coefficients c, b may be derived using astatistical regression analysis of data relating IOL power toautorefraction measurement of the spherical equivalent. For example, theregression analysis may be performed on data collected from a largepopulation of patients (e.g., one hundred patients). For each patient,the data comprise the IOL Power selected using conventional preoperativemeasurements and the spherical equivalent from an intraoperativeautorefraction.

Other relationships between the refraction measurements and the IOLpower may also be used, and the necessary constants and coefficientsderived either empirically or theoretically. One alternative, of course,is to simply combine the two formulas as follows:

IOL Power=A+c+b*(Measured Spherical Power+½Measured Cylindrical Power),

Varying the vertex distance of autorefraction or modifying the opticalmedia along the optical path (e.g., by inserting a different materialinto the anterior chamber of the eye, or by placing a temporary lens inor near the eye) can alter the parametric variables of the relationship.

In some implementations, the above formulation can be improved withadditional variables to achieve better precision. Parameters such asintraocular pressure, intraoperative axial length, intraoperativekeratometry, preoperative keratometry, preoperative axial length, intraand preoperative anterior chamber depth can be used as supplementarycorrelates in the predictive model, in order to refine the TOL power.For example, the following relationship could be used:

IOL Power=A+c+b*(Spherical Equiv)+d*(Axial Length) +f*(AverageKeratometry)+g*(Intraoperative Pressure)

In one implementation, both the surgery and the autorefraction areperformed using standard available equipment. A standard surgicalmicroscope is used for extraction of the native lens, and a standardportable autorefraction device (e.g., a Nikon Retinomax) is used forautorefraction. Both procedures may be performed while the patientremains in the same supine position. The refraction measurements areread from the autorefraction device, and the IOL power is calculatedusing a formula such as one of those given above.

FIG. 2 shows another possible implementation in which specially designedequipment is used. An autorefraction retinoscope unit 10 is attached tothe exterior of an ophthalmic surgical microscope 12. The surgicalmicroscope in this implementation has its own display for centration andvisualization. A toggle control 13 (and/or a pedal control) is providedfor XYZ centration of the microscope and the retinoscope unit. Themicroscope has the usual lens array 15. The autorefraction unit can be aconventional automated retinoscopic apparatus of the type conventionallyused to measure the dioptric deficiency and optical state of the phakiceye. The retinoscopic apparatus would be configured to operate with thepatient in the supine position, intraoperatively, and to be moved out ofthe way of the microscopic surgical device when not in use, butconfigured so that its position and orientation is adjustable using thetoggle control 13. A display unit 14 is integrated with theautorefraction unit 10 and also attached to the surgical microscope 12.The display unit presents the results of the IOL power determination. Aprocessing unit 16 is electrically connected to the autorefraction unitand the display. Cables 18 make the electrical connections between theautorefraction unit 10, display unit 14, and processing unit 16. Theprocessing unit receives measurement data from the autorefraction unit,and uses a predictive model (e.g., one of those described by the aboveformulas) to calculate the IOL power for display on the display unit.

An alternative to the arrangement shown in FIG. 2 would be to have theautorefraction unit, display unit, and processing unit fully integratedinto the ophthalmic surgical microscope. For example, the same displayunit can serve both for centration and visualization during surgery andfor controlling and displaying results from the autorefraction unit andprocessing unit during IOL power determination.

The equipment of FIG. 2 or alternative implementations may be used toperform the eye surgery, to make the intraoperative refractionmeasurement, and to calculate the IOL power for achieving the desiredemmetropia or postoperative refraction.

Many other implementations of the invention other than those describedabove are within the invention, which is defined by the followingclaims. For example, as earlier noted, completely separate surgical andautorefraction equipment may be used (e.g., with the microscope movedaway, and the autorefraction equipment moved into place), and the IOLmeasurement may be calculated from the refraction measurements withoutusing a special processor or display unit. Autorefraction may also beused after the intraocular lens is implanted (pseudophakic eye), toconfirm whether a satisfactory choice has been made for the IOL power.If the autorefraction shows a residual error, the surgeon couldimmediately remove the implanted lens, and substitute another. Varioustypes of autorefraction may be used to make the intraoperativerefraction measurement of the aphakic eye.

1-17. (canceled)
 18. A surgical method, comprising: implanting a first artificial intraocular lens into the eye of a patient; intraoperatively measuring refractive characteristics of the eye after the first artificial intraocular lens has been implanted in order to determine residual refractive error of the eye, as compared to a desired postoperative refraction, and determining whether the residual refractive error exceeds a desired amount; and intraoperatively performing a corrective action to reduce the residual refractive error if the residual refractive error exceeds the desired amount.
 19. The surgical method of claim 18, further comprising removing the natural lens from the eye before implanting the first artificial intraocular lens.
 20. The surgical method of claim 18, further comprising, before implanting the first artificial intraocular lens, determining spherical and cylindrical refractive powers for the first artificial intraocular lens, the spherical and cylindrical refractive powers being estimated to leave substantially no residual error as compared to the desired postoperative refraction.
 21. The surgical method of claim 20, wherein the spherical and cylindrical refractive powers of the first artificial intraocular lens are determined based on an aphakic measurement.
 22. The surgical method of claim 21, further comprising performing the aphakic measurement using a refractive power measurement device that is integrated with a surgical microscope.
 23. The surgical method of claim 22, wherein the refractive power measurement device comprises a wavefront-based device.
 24. The surgical method of claim 20, wherein the spherical and cylindrical refractive powers of the first artificial intraocular lens are determined based on one or more intraoperative or preoperative anatomic measurements of the eye.
 25. The surgical method of claim 24, wherein the one or more intraoperative or preoperative anatomic measurements of the eye comprise intraocular pressure, intraoperative axial length, intraoperative keratometry, preoperative keratometry, preoperative axial length, intraoperative anterior chamber depth, or preoperative anterior chamber depth.
 26. The surgical method of claim 18, wherein the corrective action comprises replacing the first artificial intraocular lens with a second artificial intraocular lens.
 27. The surgical method of claim 18, wherein determining whether the residual refractive error exceeds a desired amount comprises determining whether spherical equivalent power exceeds a desired amount of spherical equivalent power.
 28. The surgical method of claim 18, wherein determining whether the residual refractive error exceeds a desired amount comprises determining whether the astigmatic effect of the implanted first artificial intraocular lens exceeds a desired amount of astigmatic power. 